Aging, HIV
Conditions
Keywords
tDCS, Cognitive remediation therapy
Brief summary
The goal of this study is to conduct a small, self-contained project to test the hypothesis that tDCS will augment SOP cognitive remediation therapy (CRT) in older HIV+ adults. The investigators will randomly assign 60 HIV+ older adults (i.e., ≥ 50 years old) to 10-hours in either a SOP CRT + sham tDCS condition (n=30) or SOP CRT + active tDCS condition (n=30) and examine neurocognitive functioning at baseline and 6 weeks post-intervention. Hypothesis 1: The SOP CRT + active tDCS condition will show larger proximal (i.e., SOP) gains than the SOP CRT + sham tDCS condition. Hypothesis 2: The active tDCS condition will demonstrate generalization to secondary neurocognitive domains compared to the sham tDCS condition.
Interventions
DEVICEtranscranial direct current stimulation (tDCS)
tDCS is a low level electrical stimulation that will be applied to F10. The sham group will receive 2 mA (milliamps) for 30 seconds, while the experimental group will receive 2 mA for 20 minutes. Both groups will have 10, 1 hour sessions of playing cognitive remediation games, while receiving the respective level of tDCS for sham vs experimental conditions.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* HIV+ * Aged 50 and older * Patient at University HIV/AIDS Clinic
Exclusion criteria
* Not homeless * Not blind or deaf * No significant neuromedical issues (e.g., schizophrenia, bipolar disorder, stroke, epilepsy or history of seizures) * No pacemaker or other biomedical devices or metal implants * No untreated hypertension * Not undergoing chemo or radiation * No head injury with LOC greater than 30 mins
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Processing of Speed | baseline, 6 week posttest | Computerized and paper & pencil processing speed measures were used to evaluate this outcome. The Letter and Pattern Comparison Tasks are traditional paper and pencil (SOP) measures. Specifically, they assess perceptual speed. In Letter Comparison subjects are shown three sets of 32 pairs of letters containing 3, 6, or 9 segments. The participants are instructed to decide whether the patterns between the pairs are the same or different within each set, with a time limit of 20 sec per set. Pattern Comparison also presents three sets of 32 pairs of patterns with 3, 6, or 9 line segments. Similarly, participants are instructed to decide whether the patterns are the same or different within the 20 sec time limit. For each measure, the total score is the number of correct answers from all three sets. Larger scores indicate better reasoning and cognitive functioning. In this study scores from Letter and Pattern Comparison were combined for a total Letter/Pattern Score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Driving Simulator Performance | baseline, 6 week posttest | Driving Simulator Performance: Center lane crossings (a count of how many times an individual crosses the centerline during the entire simulator drive). A difference score was taken between time 2 and time 1 and compared between treatment groups (sham condition and tDCS condition). A negative difference score indicates that fewer center line crossings were made at time 2 than time 1, while positive difference scores indicate the opposite direction, and scores of 0 represent no change. |
Countries
United States
Participant flow
Recruitment details
Protocol Open to Accrual: March 2015, Primary Completion Date: January 2016 and Study Completion Date: January 2016. Recruitment location: University of Alabama at Birmingham.
Pre-assignment details
48 subjects were screened/eligible, however the phone screen did not include consenting. 42 showed up for baseline testing and were consented, thus 42 subjects were enrolled. 42 were randomized immediately after baseline testing, however 5 were either lost to followup or deemed ineligible after baseline testing. See below for further breakdown.
Participants by arm
| Arm | Count |
|---|---|
| Sham tDCS + Cognitive Remediation Subjects in the sham arm will be administered sham transcranial direct current stimulation (tDCS) (i.e., tDCS will be administered for 30 seconds and then will automatically turn off). Sham group will have identical intervention of engagement in 10 1-hour computerized cognitive remediation therapy sessions during sham tDCS as with the active tDCS condition.
transcranial direct current stimulation (tDCS): tDCS is a low level electrical stimulation that will be applied to F10. The sham group will receive 2 mA (milliamps) for 30 seconds, while the experimental group will receive 2 mA for 20 minutes. Both groups will have 10, 1 hour sessions of playing cognitive remediation games, while receiving the respective level of tDCS for sham vs experimental conditions. | 16 |
| Active tDCS + Cognitive Remediation Subjects in the active arm will be administered active transcranial direct current stimulation (tDCS) (i.e., 2.0 mA tDCS will be administered for 20 minutes and then will automatically turn off). Active group will have identical intervention engagement in 10 1-hour computerized cognitive remediation therapy sessions during active tDCS as with the sham tDCS condition.
transcranial direct current stimulation (tDCS): tDCS is a low level electrical stimulation that will be applied to F10. The sham group will receive 2 mA (milliamps) for 30 seconds, while the experimental group will receive 2 mA for 20 minutes. Both groups will have 10, 1 hour sessions of playing cognitive remediation games, while receiving the respective level of tDCS for sham vs experimental conditions. | 17 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | deemed ineligible after baseline | 1 | 1 |
| Overall Study | Lost to Follow-up | 2 | 1 |
Baseline characteristics
| Characteristic | Sham tDCS + Cognitive Remediation | Total | Active tDCS + Cognitive Remediation |
|---|---|---|---|
| Age, Continuous | 55.63 years | 55.82 years | 56 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 28 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 5 Participants | 3 Participants |
| Region of Enrollment United States | 16 participants | 33 participants | 17 participants |
| Sex: Female, Male Female | 5 Participants | 11 Participants | 6 Participants |
| Sex: Female, Male Male | 11 Participants | 22 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 19 |
| other Total, other adverse events | 0 / 18 | 0 / 19 |
| serious Total, serious adverse events | 0 / 18 | 0 / 19 |
Outcome results
Primary
Change in the Processing of Speed
Computerized and paper & pencil processing speed measures were used to evaluate this outcome. The Letter and Pattern Comparison Tasks are traditional paper and pencil (SOP) measures. Specifically, they assess perceptual speed. In Letter Comparison subjects are shown three sets of 32 pairs of letters containing 3, 6, or 9 segments. The participants are instructed to decide whether the patterns between the pairs are the same or different within each set, with a time limit of 20 sec per set. Pattern Comparison also presents three sets of 32 pairs of patterns with 3, 6, or 9 line segments. Similarly, participants are instructed to decide whether the patterns are the same or different within the 20 sec time limit. For each measure, the total score is the number of correct answers from all three sets. Larger scores indicate better reasoning and cognitive functioning. In this study scores from Letter and Pattern Comparison were combined for a total Letter/Pattern Score.
Time frame: baseline, 6 week posttest
Population: n=33 subjects were included in final analyses. Of the 37 that completed the study, 4 were deemed ineligible after they had completed the study due to confirmation with medical records they had conditions that may affect neurocognition (stroke and schizophrenia) although they self reported on the screen they did not have these conditions.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Sham tDCS + Cognitive Remediation | Change in the Processing of Speed | 2.63 units on a scale |
| Active tDCS + Cognitive Remediation | Change in the Processing of Speed | 6.06 units on a scale |
Secondary
Change in Driving Simulator Performance
Driving Simulator Performance: Center lane crossings (a count of how many times an individual crosses the centerline during the entire simulator drive). A difference score was taken between time 2 and time 1 and compared between treatment groups (sham condition and tDCS condition). A negative difference score indicates that fewer center line crossings were made at time 2 than time 1, while positive difference scores indicate the opposite direction, and scores of 0 represent no change.
Time frame: baseline, 6 week posttest
Population: While n=33 was the final sample used for the primary outcome analyses, n=30 was used for the secondary outcome as 3 subjects did not have available simulator data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Sham tDCS + Cognitive Remediation | Change in Driving Simulator Performance | 1.867 Times crossing center lane |
| Active tDCS + Cognitive Remediation | Change in Driving Simulator Performance | -1.800 Times crossing center lane |